NDC Code | 43602-320-05 |
Package Description | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-320-05) |
Product NDC | 43602-320 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate |
Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20210929 |
Marketing Category Name | ANDA |
Application Number | ANDA214959 |
Manufacturer | Ascent Pharmaceuticals, Inc |
Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
Strength | 6.25; 6.25; 6.25; 6.25 |
Strength Unit | mg/1; mg/1; mg/1; mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |